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Phakic IOL safe, effective in high myopes
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MAUI, Hawaii — The Artisan Phakic IOL (Ophtec) was found to be safe and effective for the correction of high myopia, according to a surgeon speaking here at Hawaii 2003: the Royal Hawaiian Eye Meeting.
According to Kerry K. Assil, MD, preliminary results of the phase 3 Food and Drug Administration trial showed the lens to have a low rate of complications. Follow-up to date is 3 years, he said.
The trial has enrolled 971 eyes of 560 patients at 22 centers with more than 30 investigators, he said. Preoperative error ranges were from –5 D to –20 D, Dr. Assil said. Preop uncorrected visual acuity (UCVA) was 20/400 in all patients.
“The stability of this lens was extreme,” Dr. Assil said. Surgeons should expect the axial length to increase over time because of the high level of myopia, he said. LASIK is “quite easily performed” on these patients as well, with a very low incidence of adverse events.
According to Dr. Assil, preliminary UCVA results showed a postoperative improvement to 20/40 in all patients. There have been no cases of IOP elevation, endothelial cell loss, loss of best-corrected visual acuity (BCVA), pupil decentration, cataract formation or persistent uveitis reported, Dr. Assil said.
“This lens provides relatively early and stable refraction,” he said. The key to successful surgery is to carefully pick patients, he added.
“Exclude those with protruding irises,” he said. “Surgeons need to be well-trained in this technique, but all the complications appear transient.”